JP2011528607A - Repositionable intraluminal support structure and its application - Google Patents

Abstract

The intraluminal support structure (10) includes a strut member (11) interconnected by a swivel joint (15) to form a series of coupled scissor mechanisms. This structure can be remotely actuated to compress or expand its shape by adjusting the scissor joint within the range of motion. Specifically, the support structure can be repositioned within the body lumen or retrieved from the lumen. The support structure can be used to introduce and support the prosthetic valve (100) within the body lumen.

Description

(Cross-reference of related applications)
This application claims the benefit of US Provisional Patent Application No. 61 / 082,489 (named “Prosthetic Valve with Rotating Leaflets and Retrievable Support”, filed July 21, 2008, applicant “Jennifer K. White”). The entire teachings of this application are incorporated herein by reference.

  Intraluminal stents can be implanted in a patient's lumen or tube to help maintain an open lumen. A stent can also be used as a frame to support a prosthesis or to deliver a therapeutic agent. The stent can be implanted by either an open surgical procedure or a closed surgical procedure. If selected, a less invasive closure procedure is generally preferred because the stent can be guided through a body lumen such as the femoral artery to its desired site. Closure procedures typically use one of two techniques.

  One closure procedure uses balloon catheterization in which an expandable stent surrounds an inflatable balloon. In this procedure, the stent is implanted by inflating the balloon, thereby expanding the stent. The actual positioning of the stent cannot be determined until after the balloon is deflated, and if the stent is misplaced, the process cannot be reversed to reposition the stent.

  The other closure procedure uses a compressed stent surrounded by a removable sheath. In this procedure, a stent made from a shape memory alloy such as nitinol is held in a compressed state by a sheath. The stent is implanted by retracting the sheath, thereby expanding the stent to its nominal shape. Again, if the stent is misplaced, the process cannot be reversed to reposition the stent.

  Positioning errors are particularly dangerous when using a stent to support a heart valve. Serious complications and patient deaths have occurred due to valve position abnormalities at the implantation site in the body using available stent-mounted valves. Valve position abnormalities have resulted in massive paravalvular leakage, device movement, and coronary artery occlusion. Most of these complications are unavoidable but are detected at the time of treatment. However, these problems cannot be reversed or alleviated during the procedure because device relocation or recovery is not possible.

  Intraluminal support structures or stents according to certain embodiments of the present invention solve certain deficiencies found in the prior art. Specifically, the support structure can be repositioned within the body lumen or retrieved from the lumen.

  Certain embodiments of the present invention include a support device that is implantable within a biological lumen. The support device can include a plurality of elongate strut members interconnected by a plurality of swivel joints, the swivel joints including a stent member to adjustably define a molded structure between a compression orientation and an expanded orientation. Can cooperate.

  More specifically, the forming structure can be one of a cylindrical shape, a conical shape, or an hourglass shape. The swivel joint can form a scissor mechanism by the first strut member and the second strut member. Further, the strut member can be configured as a series of connected scissor mechanisms. The apparatus can further include an actuation mechanism that biases the swivel joint within the range of motion.

  The apparatus can also include a prosthetic valve coupled to the molded structure.

  Another particular embodiment of the present invention can include a medical stent that is implantable within a biological lumen. The medical stent can include a plurality of elongated strut members including a first strut member and a second strut and a swivel joint connecting the first strut member and the second strut member.

  Specifically, the swivel joint can form a scissor mechanism with the first strut member and the second strut member. The swivel joint can bisect the first strut member and the second strut member. The swivel joint can interconnect the first end of the first strut member to the first end of the second strut member.

  The plurality of strut members can be configured as a series of connected scissor mechanisms. Also, the strut member can be non-linear. The strut member can be configured to form one of a cylindrical shape, a conical shape, or an hourglass shape.

  The stent may further include an adjustment mechanism that applies a force that biases the strut member about the swivel joint within a range of motion.

  The stent can include a prosthetic valve coupled to the strut member.

  Specific embodiments of the invention can include rotatable or conventional prosthetic valves.

  The rotatable prosthetic valve includes a first structural member coupled to the strut member, a second structural member rotatable relative to the first structural member, and a second structural member relative to the first structural member. A plurality of flexible valve members connecting the first structural member to the second structural member such that the rotation of the first structural member biases the valve member between an open state and a closed state. Specifically, the rotation of the second structural member can respond to the natural flow of body fluid.

  Conventional prosthetic valves can include a plurality of flexible leaflets that have seams at the intersection of two strut members. The prosthetic valve can further include a skirt material coupled to the strut member.

  A particular advantage of the support structure according to embodiments of the present invention is that the prosthetic valve can be easily retrieved and repositioned in the body. If after deployment, the valve is considered misaligned or dysfunctional, the support structure allows the valve to be easily repositioned and redeployed to a new implantation site or removed completely from the body. This feature of the device can prevent serious complications and save lives by allowing repair of misplaced devices in the body.

The foregoing and other objects, features, and advantages of the present invention will become apparent from the more specific description of specific embodiments of the present invention as illustrated in the accompanying drawings, in which the same reference characters are used in the accompanying drawings. The same parts are referred to in different drawings. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention.
FIG. 1 is a perspective view of a particular intraluminal support structure. FIG. 2 is a perspective view of the four strut sections of the stent of FIG. 3 is a perspective view of the compressed support structure of FIG. 4 is a perspective view of the support structure of FIG. 1 in a fully expanded state. FIG. 5 is a perspective view of the support structure of FIG. 2 having a particular actuator mechanism. 6 is a perspective view of the support structure of FIG. 2 having another specific actuator mechanism. FIG. 7 is a perspective view of a particular support structure and control catheter assembly that can be used with the actuator mechanism of FIGS. 5 and 6. FIG. 8 is a perspective view of a particular rotary prosthetic valve assembly. FIG. 9 is a perspective view of the valve assembly of FIG. 8 during closure. FIG. 10 is a perspective view of the valve assembly of FIG. 8 after full closure. 11 is a perspective view of the valve of FIGS. 8-10 in combination with the support structure of FIG. 12 is a perspective view of the valve of FIG. 11 in the open position. FIG. 13 is a perspective view of a conventional tissue valve mounted on the support structure of FIG. 14 is a perspective view of the valve structure of FIG. 13 having a complete inner skirt. FIG. 15 is a perspective view of the valve structure of FIG. 13 having a complete outer skirt. FIG. 16 is a perspective view of the arrangement of strut members in a conical support structure configuration. FIG. 17 is a perspective view of an hourglass-shaped support structure configuration.

  Certain embodiments of the invention include an endoluminal support structure (stent) and a prosthetic valve.

  FIG. 1 is a perspective view of a particular intraluminal support structure. As shown, the support structure 10 is a medical stent that includes a plurality of longitudinal strut members 11 interconnected by a plurality of swivel joints 15. Specifically, the strut members 11 interconnected by the swivel joint 15 can be rotated with respect to each other. As shown, there are 18 struts 11.

  The strut member 11 is a rigid or semi-rigid biocompatible material such as plastics or other polymers and metal alloys including stainless steel, tantalum, titanium, nickel-titanium (eg, Nitinol), and cobalt-chromium (eg, ELGILOY). Made from sex material. The dimensions of each strut can be selected according to its desired use. In certain embodiments, each strut member is made from stainless steel 0.005-0.020 inches thick. More specifically, each strut is 0.010 inch thick 300 series stainless steel. Although all struts 11 are shown to have a uniform thickness, the strut thickness can vary from strut to strut, such as gradually increasing or decreasing along the strut length. . Furthermore, individual struts can have a different thickness than other individual struts in the same support structure.

  As shown in the figure, each strut member 11 has a bar shape and has a front surface 11f and a back surface 11b. However, the strut members can have different geometric shapes. For example, instead of being uniform in width, the strut width can vary along its length. Furthermore, individual struts can have a different width than other struts in the same support structure. Similarly, the strut length can vary with struts in the same support structure. Specific dimensions can be selected based on the implantation site.

  Furthermore, the struts can be non-planar structures. Specifically, the strut can include a curvature such as concave or convex with respect to the inner diameter of the stent structure. The struts can also be twisted. Strut non-flatness or flatness can be a property of the material from which the strut is constructed. For example, struts exhibit shape memory or shape changes in thermal response to the struts during various states. Such a condition can be defined by a stent in a compressed or expanded configuration.

  Furthermore, the strut member 11 can have a smooth surface property or a rough surface property. Specifically, the direction of the depression can provide tensile strength to the strut. In addition, the roughness or indentation can provide additional friction, can help secure the support structure at the implantation site, and irregular encapsulation of the support structure 10 by tissue growth can result in support structure 10 at the implantation site. Can be further stabilized over time.

  In certain instances, a stent may be composed of struts that are members that are stacked on top of each other. Within the same stent, some struts may include elongate members stacked on top of each other in a multi-layer configuration, while others may be single layer struts composed of a single thickness member. Within a single strut, there can be single and multi-layer stacking ranges of members.

  Each strut member 11 also includes a plurality of orifices 13 spaced along the length of the strut member 11. On the front face 11f, the orifice is a counterbore 17 that houses the head of the fastener. In certain embodiments, there are thirteen equally spaced orifices 13 along the length of each strut member 11, although more or fewer orifices can be used. The orifices 13 are shown as having a uniform diameter and uniform spacing along the strut member 11, but neither is essential.

  The strut member 11 is configured as a chain of four rods. The strut members 11 are interconnected by a pivotable pivoting fastener 25 such as a rivet that passes through the aligned orifice 13. Other pivotable fasteners 25 such as screws, bolts, ball joint structures, nails, or eyelets can be used and peened hemispheres that interact with recesses or orifices, or male-female couplers, etc. It should be understood that the fastener can be integrally formed with the strut 11. In addition to housing the fasteners, the orifice 13 also provides an additional path for tissue growth to stabilize and encapsulate the support structure 10 over time.

  FIG. 2 is a perspective view of the four strut sections of the stent of FIG. As shown in the drawing, the two outer strut members 11-1 and 11-3 overlap the two inner strut members 11-2 and 11-4, and the back surfaces thereof are in communication with each other.

  Specifically, the first strut member 11-1 is pivotally connected to the second strut member 11-1 by a central swivel joint 15-1 using a rivet 25-1, and the central swivel joint 11-1. 15-1 uses an orifice 13 that divides the strut members 11-1 and 11-2 into two equal parts. Similarly, the third strut member 11-3 is pivotally connected to bisect the fourth strut member 11-4 by a central swivel joint 15-7 using a rivet 25-7. The It should be understood that the central swivel joints 15-1, 15-7 function as scissor joints in the scissor connection or mechanism. As shown, the resulting scissor arms have equivalent lengths. Further, the central joint portions 15-1 and 15-7 do not need to bisect the joined strut members, and instead, using the orifice 13 that is offset from the longitudinal center of the strut members, It should also be understood that this results in no arm length.

  In addition to the central scissor joint 15-1, the first strut member 11-1 is connected to the third by a distal anchor swivel joint 15-5 located near the distal end of the strut members 11-1, 11-3. The strut member 11-3 is pivotally connected. Similarly, the first strut member 11-1 is pivoted to the fourth strut member 11-4 by a proximal anchor swivel joint 15-3 located near the proximal end of the strut members 11-1, 11-4. Connected as possible. In order to reduce stress on the anchor rivets 25-3, 25-5, the distal and proximal ends of the struts 11 are curved or twisted to provide a flat interface between the joined struts. Can be.

  As shown, the support structure 10 (FIG. 1) is fabricated by connecting a chain of successive scissor mechanisms. This chain is then wrapped to join the last scissor mechanism in a chain with the first scissor mechanism. By actuating the connection, the annulus can be opened or closed, which results in expansion or compression of the stent 10 (FIG. 1).

  Referring again to FIG. 1, by utilizing the swivel joint 15, the stent diameter can be compressed and inserted into a biological lumen such as an artery. The stent can then be expanded to secure the stent at a selected location within the lumen. Further, after expansion, the stent can be compressed again and removed from the body or repositioned within the lumen.

  3 is a perspective view of the compressed support structure of FIG. Upon compression, the stent 10 is at its maximum length and minimum diameter. The maximum length is limited by the length of the strut member, and in certain embodiments is 15 mm. The minimum diameter is limited by the width of the strut member and in a particular embodiment is 0.052 inches.

  4 is a perspective view of the support structure of FIG. 1 in a fully expanded state. As shown, the fully expanded support structure 10 forms a ring that can be used as an annuloplasty ring.

  Specifically, when one end of the stent circumference is attached to the tissue, the tissue can be clamped by compression of the stent. Because the stent has the ability to have incremental and reversible compression or expansion, the device can be used to provide individual tightening of tissue to enhance the capacity of the heart valve. This can be a useful treatment for mitral valve disease such as mitral regurgitation or mitral valve prolapse.

  Although the support structure 10 can be implanted into a patient during an open surgical procedure, a closure procedure is often more desirable. Accordingly, the support structure 10 can include an actuation mechanism, which allows the surgeon to expand or compress the support structure from a location remote from the implantation site. Due to the nature of the cylindrically wound scissor connection (FIG. 1), the actuation mechanism either by increasing the distance between adjacent scissor joints or by reducing the distance between anchor joints. Can function to expand the stent diameter.

  FIG. 5 is a perspective view of the support structure of FIG. 2 having a particular actuator mechanism. As shown, the actuator mechanism 30 includes a double threaded rod 32 positioned within the support structure 10 (FIG. 1). However, it should be understood that the actuator mechanism 30 may instead be located outside the support structure 10. Regardless of whether it is positioned inside or outside, the actuator mechanism 30 operates similarly.

  The rod includes a right-hand thread 34R at its proximal end and a left-hand thread 34L at its distal end. Rod 32 is attached to anchor points 15-3, 15-5 using a pair of threaded low profile support fixtures 35-3, 35-5. Each end of the rod 32 is terminated by hexagon heads 37-3 and 37-5 for accommodating hexagonal drivers (not shown). As will be appreciated, by rotating the rod 32 in one direction, the anchor points 25-3, 25-5 are biased outward to compress the connection and by rotating the rod 32 in the opposite direction. Anchor points 25-3, 25-5 are biased inward to expand the connection.

  6 is a perspective view of the support structure of FIG. 2 having another specific actuator mechanism. As shown, the actuator mechanism 30 'includes a single threaded rod 32' positioned within the support structure 10 (FIG. 1). The rod 32 'includes a thread 34' on one of its ends. The rod 32 'is attached to the low profile anchor points 15-3, 15-5 using a pair of support attachments 35'-3, 35'-5, and the support attachments 35'-3, 35'-. One of the five has a thread to mate with the rod thread 34 '. The unthreaded end of the rod 32 'includes a retention stop 39' positioned against the support fitting 35'-5 so as to compress the support structure. Each end of the rod 32 'is terminated by a hexagon head 37'-3, 37'-5 for accommodating a hexagon driver (not shown). As described above, by rotating the rod 32 'in one direction, the anchor points 25-3, 25-5 are biased outward, compressing the connection, and rotating the rod 32' in the opposite direction. As a result, the anchor points 25-3 and 25-5 are urged inward to expand the connection.

  In addition, since the struts overlap, a ratchet mechanism can be incorporated for use while one strut slides relative to the other strut. For example, the stent can lock in incremental diameters due to the characteristic interface that is an integral part of each strut. An example of such a feature is a male component on one strut surface that mates with a female component (eg, a hole) on an adjacent strut surface such that two struts slide past each other. (Eg, a bump). Such a structure can be fabricated to have an orientation that incrementally locks the stent to the expanded configuration when the stent is expanded. Such stents can be expanded using conventional balloons or other actuation mechanisms described in this application.

  Since the support structure 10 of FIGS. 5 and 6 is intended to be implanted during a closed surgical procedure, the actuator mechanism is remotely controlled by the surgeon. In a typical procedure, the support structure 10 is implanted through a body lumen such as a femoral artery using a tethered intraluminal catheter. Thus, the actuator mechanism 30 can be controlled via the catheter.

  FIG. 7 is a perspective view of a particular support structure and control catheter assembly that can be used with the actuator mechanism of FIGS. 5 and 6. The control catheter 40 is dimensioned to be inserted with a support structure through a biological lumen such as a human artery. As shown, the control catheter 40 has a flexible drive cable 42 having a driver 44 on its distal end that removably mates with the hexagonal heads 37, 37 ′ of the actuator mechanism (FIGS. 5 and 6). including. The proximal end of cable 42 includes a hexagon head 46. During operation, the proximal hex head 46 of the cable 42 is rotated by the surgeon using a thumbwheel or other suitable manipulator (not shown). The rotation of the hexagonal head 46 is transmitted to the driver head 44 by the cable 42, and rotates the actuator rods 30, 30 '(FIGS. 5 and 6).

  Cable 42 is encapsulated by a flexible outer sheath 48. The distal end of the outer sheath 48 includes a lip or protrusion 49 that is shaped to interact with the support structure 10. As cable 42 rotates, outer sheath lip 49 interacts with support structure 10 to counter the resulting torque.

  By using threads, the rod is self-locking to maintain the support structure at the desired diameter. In a particular embodiment, the rods 32, 32 'have a diameter of 1.0 mm and a screw speed of 240 revolutions / inch. Although threaded rods and drive mechanisms are described, other approaches may be used to actuate the connection, depending on the particular surgical application. For example, the actuator mechanism may be placed within the thickness of the strut member instead of inside or outside the stent. For example, a worm gear or rack and pinion mechanism may be used, as is known in the art. Those skilled in the art will recognize other endoluminal actuation techniques. In other situations, the support structure can be implanted during the opening procedure, in which case no external actuation mechanism may be required.

  While there are other uses for the support structure described above, such as drug delivery, certain embodiments support a prosthetic valve. Specifically, the support structure is used in combination with an artificial valve for aortic valve replacement or the like.

  FIG. 8 is a perspective view of a particular rotary prosthetic valve assembly. The prosthetic valve 100 includes three leaflet configurations shown in the open position. The leaflets are animal pericardium (eg, cow, pig, horse), human pericardium, chemically treated pericardium, glutaraldehyde treated pericardium, tissue engineered material, tissue engineered Derived from biocompatible materials, such as scaffolds for autoclaved materials, autologous pericardium, cadaveric pericardium, nitinol, polymer, plastic, PTFE, or any other material known in the art.

  The leaflets 101a, 101b, and 101c are attached to the stationary cylindrical member 105 and the unsteady cylindrical member 107. One side of each leaflet 101 is attached to the unsteady cylindrical member 107. The opposite side of each leaflet 101 is attached to a stationary cylindrical member 105. Each leaflet 101 is attached in a direction that is substantially perpendicular to the longitudinal axis of the cylindrical members 105, 107. In this embodiment, each leaflet 101 is flexible, generally rectangular, and has a 180 degree twist between its attachment to the stationary member 105 and the unsteady member 107. Each leaflet 101 has an inner edge 102 and an outer edge 103, and the edges 102c and 103c of one leaflet 101c are referred to in the drawings. As is known in the art, the leaflets can be made from either biological or non-biological materials, or combinations thereof.

  One method of closing the valve is by utilizing the force exerted by changes in normal blood flow or blood pressure during the cardiac cycle. More specifically, the heart discharges blood through a fully open valve in the direction of the arrow shown in FIG. Immediately thereafter, the distal or downstream blood pressure begins to rise relative to the proximal pressure at the valve, creating a back pressure at the valve.

  FIG. 9 is a perspective view of the valve assembly of FIG. 8 during closure. This back pressure along the direction of the arrow causes axial displacement of the leaflet 101 and the unsteady member 107 toward the steady cylindrical member 105. As the leaflet 101 moves from a vertical to a horizontal plane with respect to the longitudinal axis, a net counterclockwise torque force is exerted on the unsteady member 107 and the leaflet 101. The torque force causes the centripetal force to act on the leaflet 101.

  FIG. 10 is a perspective view of the valve assembly of FIG. 8 after full closure. As shown, complete closure of the valve 100 occurs when the leaflet 101 is displaced to the center of the valve and the unsteady cylindrical member 107 is on the stationary member 105.

  The function of opening the valve 100 can be understood by observing the reverse of the valve closing step, that is, according to the order of the diagrams of FIGS.

  Considering valve 100 as an aortic valve replacement, the valve may remain closed as shown in FIG. 10 until the heart enters systole. During systole, when the myocardium contracts strongly, the blood pressure exerted on the proximal side of the valve (the side closest to the heart) is greater than the pressure on the distal side (downstream) of the closed valve. Due to this pressure gradient, the valve leaflet 101 and the unsteady cylindrical member 107 are displaced away from the steady member 105 along the axial plane. In brief, the valve 100 assumes the semi-closed transition state shown in FIG.

  As the leaflet 101 extends from the horizontal orientation to the vertical orientation along the axial plane, a net torque force is exerted on the leaflet 101 and the unsteady cylindrical member 107. As the valve 100 opens, the torque force exerted to open the valve, as opposed to closing, is the opposite of the force exerted to close the valve. Considering the configuration of the embodiment shown in FIG. 9, the torque force that opens the valve may be in a clockwise direction.

  Due to the torque force, the leaflet 101 rotates with the unsteady member 107 about the longitudinal axis of the valve 100. This in turn causes a centrifugal force to act on each leaflet 101. The leaflet 101 undergoes a radial displacement away from the center, effectively opening the valve and allowing blood to flow away from the heart in the direction indicated by the arrows in FIG.

  In summary, the valve functions passively to provide unidirectional blood flow by connecting three forces. Axial torque forces and radial forces are converted in a sequential and reversible manner and encode the direction of previous motion. Initially, axial forces of blood flow and blood pressure cause displacement of the leaflet 101 and the unsteady member 107 relative to the stationary member 105 along the axial plane. This is converted into a rotational force on the leaflet 101 and the unsteady member 107. The torque force then displaces the leaflet 101 along the radial plane toward or away from the center of the valve and closes or opens the valve 100. The valve 100 passively follows an open or closed path depending on the direction of the axial force initially applied to the valve by the cardiac cycle.

  Within the body, the stationary cylindrical member 105 can be fixed and secured in place at the implantation site, and the non-stationary member 107 and the distal end of the leaflet 101 are freely displaced along the axial plane. When using a prosthetic valve as an aortic valve replacement, the stationary member 105 can be secured to the aortic base. As blood pressure or blood flow from the heart increases, the valve 100 changes from its closed configuration to an open configuration with blood being discharged from the valve 100.

  Specific advantages of the rotary valve of FIGS. 8-10, as well as further embodiments, are illustrated in the provisional patent application of the above incorporated patent.

  11 is a perspective view of the valve of FIGS. 8-10 in combination with the support structure of FIG. As shown in the closed position, the valve stationary member 105 is attached to the support structure 10. The unsteady member 107 of the valve is not attached to the support structure 10. This allows the unsteady member 107 to be displaced along with the leaflets 101 along the axial plane during the opening or closing of the valve. In this particular embodiment, the valve 100 occupies a position near one end of the support structure 10 as shown.

  12 is a perspective view of the valve of FIG. 11 in the open position. As described above, since the unsteady member 107 is not attached to the support structure 10, it is freely displaced along with the leaflet 101 along the axial plane. In this particular embodiment, the unsteady member 107 and leaflet 101 remain within the support structure 10 while fully open.

  The stent-type valve 110 can be implanted during a closure procedure as described above. However, due to the movement of the unsteady member within the body of the stent, the actuator mechanism that compresses and expands the stent cannot be placed within the stent.

  Further embodiments of the stent-type valve 110, positioning of the valve within the body, and implantation procedures are described in the provisional patent application incorporated above. In addition, the tissue valve can be draped on the support structure. Additional embodiments should be apparent to those skilled in the art.

  FIG. 13 is a perspective view of a conventional tissue valve mounted on the support structure of FIG. As shown, the stent-type valve 120 includes a prosthetic valve 121 that is attached to a support structure 10 such as the support structure described above.

  The tissue valve 121 includes three flexible semi-circular leaflets 121a, 121b, 121c, which can be derived from a biocompatible material, as described in connection with FIG. Adjacent leaflets are paired and attached to seams 123x, 123y, 123z on support structure 10. Specifically, the seams 123x, 123y, 123z correspond to spaced distal anchor points 13x, 13y, 13z on the support structure 10. In an 18 strut stent, seams are attached to the structure 10 via corresponding fasteners 25 every two distal anchor points.

  From the seam, the leaflet side is connected to adjacent diagonal struts. That is, the side surface of the first valve leaflet 121a is sutured to the struts 11-Xa and 11-Za, respectively, and the side surface of the second valve leaflet 121b is sutured to the struts 11-Xb and 11-Yb, respectively. The side surfaces of the valve leaflets 121c are sutured to the struts 11-Yc and 11-Zc, respectively. These sutures terminate at scissor pivot points on the diagonal struts.

  In the illustrated configuration, adjacent struts 11 are attached to each other to create a plurality of arches 128 at the ends of the stent. A post or seam for leaflet attachment is formed by attaching an adjacent leaflet to each of the struts defining the appropriate arch 128x, 128y, 128z. In the configuration shown, there are three leaflets 121a, 121b, 121c, each of which is attached to the strut along two of its opposite boundaries. The seam is formed by three equally spaced arches 128x, 128y, 128z in the stent.

  The leaflets 121a, 121b, 121c are attached to the stent in a triangular configuration due to the tilt orientation of the struts associated with its adjacent struts. This triangular configuration simulates the sloped attachment of the natural aortic leaflet. In natural valves, this creates an anatomical structure between the leaflets known as the inner leaflet triangle. Since the anatomical medial leaflet triangle is believed to provide structural integrity and durability to the human natural aortic leaflet, it is advantageous to simulate this structure in a prosthetic valve.

  One way to attach the leaflets to the struts is to sandwich the leaflets between multilayer struts. The multiple layers are then held together by stitching. Holding the leaflets between the struts helps dissipate force on the leaflets and prevent tearing of the sutures through the leaflets.

  The remaining sides of each leaflet 121a, 121b, 121c are sutured annularly across the intermediate strut member as indicated by the leaflet seam. The remaining open space between the struts is draped by the biocompatible skirt 125 to help seal the valve to the implantation site and thus limit paravalvular leakage. As shown, the skirt 125 is shaped to cover these portions of the stent under and between the leaflets.

More particularly, the skirt 125 at the base of the valve is a thin layer of material that lines the stent wall. The skirt material can be pericardial tissue, polyester, PTFE, or any other material or combination of materials suitable to receive the growing tissue, a chemistry that promotes tissue growth or prevents infection Processed material is included. The skirt layer functions to reduce or eliminate leakage around the valve, ie paravalvular leakage. To this end, there are a number of ways to attach the skirt material layer to the stent, including:
The skirt layer can be on the inside or the outside of the stent;
The skirt layer can occupy the lower part of the stent;
The skirt layer can occupy the lower and upper portions of the stent;
The skirt layer can occupy only the upper part of the stent;
The skirt layer can occupy the area between the struts defining the column of seams;
The skirt layer can be continuous with the leaflet material;
The skirt layer can be sutured to struts or multiple sites; or
The skirt layer can be secured to the lower portion of the stent and pulled or pressed to cover the exterior of the stent during deployment into the body.

  The above list is not necessarily limiting, as one skilled in the art can recognize alternative drape techniques for specific applications.

  14 is a perspective view of the valve structure of FIG. 13 having a complete inner skirt. The stent-type valve 120 ′ includes a prosthetic valve 121 ′ having three leaflets 121 a ′, 121 b ′, 121 c ′ attached to the support structure 10. The skirt layer 125 ′ covers the inner surface of the stent 10. Accordingly, the leaflets 121a ', 121b', 121c 'are stitched to the skirt layer 125'.

  FIG. 15 is a perspective view of the valve structure of FIG. 13 having a complete outer skirt. The stent-type valve 120 ″ includes a prosthetic valve 121 ″ having three leaflets 121a ″, 121b ″, 121c ″ attached to the support structure 10, as illustrated in FIG. 13. The skirt layer 125 ″ is a stent. 10 outer surfaces are coated.

  Also, the tissue valve structures 120, 120 ′, 120 ″ can be implanted during a closure procedure, as described above. However, an actuator mechanism for compressing and expanding a stent causes the actuator mechanism to be on the outer surface of the stent 10. It can be attached to avoid seam points, such as by mounting, and to limit damage to the skirt layers 125, 125 ′, 125 ″.

  While the above-described embodiments address a support structure having a linear strut bar and an equal length scissor arm, other geometric shapes may be used. The resulting shape is other than cylindrical and can have better performance in certain applications.

  FIG. 16 is a perspective view of the arrangement of strut members in a conical support structure configuration. In the conical structure 10 ′, the strut member 11 is arranged as shown in FIG. 2 except that the central scissor turning part does not divide the strut into two equal parts. Specifically, the central scissor swivel part (for example, 15′-1, 15′-7) is connected to the strut member (for example, 11′-1, 11′-2 and 11′-3, 11′4). ) Is divided into unequal sections of 5/12 length and 7/12 length. When fully assembled, the resulting support structure conforms to the conical shape when expanded. For illustrative purposes, the stent 10 'is shown including a single threaded actuator rod 32' (FIG. 6), but is not an essential element of this stent embodiment.

  The stent 10 'can also assume a conical shape in its expanded configuration by imparting a convex or concave curvature to the individual strut members 11 comprising the stent 10'. This can be accomplished by using a material with memory, such as shape memory or temperature sensitive nitinol.

  The valve can be oriented with the conical stent 10 'so that the base of the valve is in the narrow portion of the conical stent and the non-base portion of the valve is in the wide portion of the cone. Alternatively, the base of the valve may be located at the widest portion of the stent and the non-base portion of the valve may be at a portion that is not wider.

  The orientation of the conical stent 10 'in the body can either be towards or away from the blood flow. In other body lumens (eg, airways or gastrointestinal tract), the stent can be oriented in either direction relative to the axial plane.

  FIG. 17 is a perspective view of an hourglass-shaped support structure configuration. In this configuration, the circumference around the central pivot points 15 ″ -1, 15 ″ -7, 15 ″ -9 (necked portion) is smaller than the circumference at both ends of the stent 10 ″. As shown, the hourglass-shaped support structure 10 "is achieved by reducing the number of strut members 11" to 6 and shortening the strut members 11 "compared to the previous embodiment. , The number of orifices 13 "per strut member 11" is reduced. Depending on the number and geometry of the struts, each strut member 11 "includes a twist at points 19" along three longitudinal planes. The twist provides a flat interface between the joined struts 15 "-3.

  An hourglass stent configuration can also be achieved by imparting a convex or concave curvature to the individual rod 11 ″. This curvature can be a property of the material (eg, shape memory or thermal nitinol). Appears when the stent is in its expanded state, not in the stented state.

  Note that any of the support structures described above can extend beyond the anchor junction at either of the ends of the stent. Additional stent lengths and geometries can be fabricated by joining a series of stents in an end-to-end linkage fashion. Specifically, an hourglass stent can be achieved by joining two conical stents at their two narrow ends. Also, the hourglass shape can be corrected by disassembling the central scissor swivel as shown in FIG.

  Certain embodiments of the present invention provide clear advantages over the prior art including its structure and application. Although certain advantages are summarized below, the summaries are not necessarily a complete list because additional advantages may exist.

  The device allows the user to avoid serious complications that can occur during percutaneous heart valve implantation. Because the device is retrievable and repositionable during implantation into the body, the surgeon can avoid serious complications due to valve misplacement or movement during implantation. Examples of these complications include coronary artery occlusion, massive paravalvular leakage, or arrhythmia.

  The device can also reduce vascular access complications due to the narrow insertion profile of the device. The device profile is low due in part to its unique geometry, which allows adjacent struts in the stent to overlap during stent compression. The low profile of the device is further reinforced by eliminating the need for a balloon or sheath. The narrow profile of the device offers the advantage of expanding vascular access pathway options in patients. For example, the device allows for the delivery of a prosthetic valve through the artery of the patient's leg, and previously the patient would have undergone a more invasive procedure through the chest wall. The device is therefore aimed at reducing the complications associated with the use of large profile devices in patients with poor vascular access.

  Tissue valve embodiments can provide improved durability by allowing attachment of a leaflet to a flexible joint. The flexible column allows the dissipation of stress and strain applied to the leaflets by the cardiac cycle. The use of multi-layer struts allows the leaflets to be sandwiched between struts, the leaflet attachment is performed again, and sutures are prevented from tearing. In addition, the valve assumes the desired leaflet shape, which reduces stress and strain on the leaflet. That is, the attachment of a beveled leaflet to a stent is similar to the intervertebral inner triangular pattern of a natural human aortic valve. These properties greatly improve the lifetime of percutaneous heart valve replacement therapy.

  This device may reduce or eliminate arrhythmia complications due to incremental expansion or compression of the stent. The stent can use a screw mechanism for deployment, which allows the stent to automatically lock or unlock at all radii. This allows for more controlled deployment and the possibility of individualizing device expansion or compression in each patient. Because the expansion or compression of the device is reversible at any stage during the procedure, the surgeon can easily reverse the expansion of the device to reduce arrhythmias. In addition, if an arrhythmia is detected during implantation, the device can be repositioned to further eliminate the problem.

  This device can reduce or eliminate paravalvular leakage due to the ability of the device to be accurately positioned and repositioned as needed. As a result, the occurrence and severity of paravalvular leakage can be greatly reduced.

  This device eliminates balloon-related complications. The deployment screw mechanism takes advantage of the mechanical advantages of screws. This provides for strong expansion of the stent. A lever arm created by the pivoting of the struts in the stent scissors connection transmits further expansion force to the stent. The stent is expanded without the need for a balloon. In addition, the ability of the device to be strongly inflated reduces or eliminates the need before or after ballooning during the implantation procedure in the patient.

  This device has a more predictable and accurate positioning within the body due to the small difference in stent height between the compressed and expanded positions. This “reduced shortening” helps the surgeon position the device at the desired location in the body. The ability to reposition the device within the body further provides the ability to accurately position the device in each individual.

  In addition to mechanical advantages, the device allows a wider patient population to be treated by minimally invasive means for valve replacement. For example, the device can provide treatment options for patients with co-morbidities that are not amenable to open heart valve replacement. In addition, the device's ability to take on a narrow profile can provide treatment options for patients who have previously been denied treatment due to poor vascular access (eg, tortuous, calcified, or small arteries) become. Due to the durability of the valve, the use of minimally invasive procedures should expand to a healthy patient population that can accommodate open heart surgery valve replacement if not refused. The ability of the device to expand strongly or assume an hourglass or conical shape potentially expands the device's application to the treatment of patients diagnosed with aortic regurgitation as well as aortic stenosis.

  The device can also provide a minimally invasive therapy to patients with degenerative prostheses from conventional implants by providing a “valve-in-valve” procedure. The device can be accurately positioned inside the failure valve without removing the patient's deformed prosthesis. This helps the patient by providing functional valve replacement without including the “redo” action and associated risks.

  Although the invention has been particularly shown and described with reference to specific embodiments, various changes can be made in form and detail without departing from the scope of the invention as encompassed by the appended claims. It should be understood by those skilled in the art that it may be added to the form.

A particular advantage of the support structure according to embodiments of the present invention is that the prosthetic valve can be easily retrieved and repositioned in the body. If after deployment, the valve is considered misaligned or dysfunctional, the support structure allows the valve to be easily repositioned and redeployed to a new implantation site or removed completely from the body. This feature of the device can prevent serious complications and save lives by allowing repair of misplaced devices in the body.
(Item 1)
A support device implantable in a body lumen,
A plurality of elongate strut members interconnected by a plurality of swivel joints, the swivel joints cooperating with the stent members to definitively define the forming structure between a compression orientation and an expansion orientation.
A support device comprising:
(Item 2)
The apparatus of claim 1, further comprising an actuating mechanism that biases the swivel joint within a range of motion.
(Item 3)
The apparatus according to item 1, wherein the swivel joint forms a scissor mechanism by the first strut member and the second strut member.
(Item 4)
The apparatus of claim 3, wherein the strut members are configured as a series of connected scissor mechanisms.
(Item 5)
The apparatus of claim 1, further comprising a prosthetic valve coupled to the molded structure.
(Item 6)
The artificial valve is
A first structural member coupled to the strut member;
A second structural member rotatable relative to the first structural member;
A plurality of flexible valve members for connecting the first structural member to the second structural member, the rotation of the second structural member relative to the first structural member in an open state by the connection; A plurality of flexible valve members biasing the valve member between closed states;
The apparatus according to item 5, comprising:
(Item 7)
Item 7. The apparatus of item 6, wherein rotation of the second structural member is responsive to a natural flow of bodily fluid.
(Item 8)
6. The apparatus of item 5, wherein the prosthetic valve includes a plurality of flexible leaflets having a seam at the intersection of two strut members.
(Item 9)
The apparatus of claim 8, wherein the prosthetic valve includes a skirt material coupled to the strut member.
(Item 10)
The apparatus of item 1, wherein the forming structure is one of a cylindrical shape, a conical shape, or an hourglass shape.
(Item 11)
A medical stent implantable in a body lumen,
A plurality of elongated strut members including a first strut member and a second strut;
A swivel joint connecting the first strut member and the second strut member;
A medical stent comprising:
(Item 12)
Item 12. The stent according to Item 11, wherein the swivel joint forms a scissor mechanism by the first strut member and the second strut member.
(Item 13)
The stent according to item 12, wherein the swivel joint bisects the first strut member and the second strut member.
(Item 14)
13. The stent of item 12, wherein the plurality of strut members are configured as a series of connected scissor mechanisms.
(Item 15)
Item 12. The stent of item 11, wherein the swivel joint interconnects a first end of the first strut member to a first end of the second strut member.
(Item 16)
Item 12. The stent according to Item 11, further comprising an adjustment mechanism for applying a force to bias the strut member around the swivel joint within a range of motion.
(Item 17)
Item 12. The stent of item 11, wherein the strut member is non-linear.
(Item 18)
12. The stent of item 11, further comprising a prosthetic valve coupled to the strut member.
(Item 19)
The artificial valve is
A first structural member coupled to the strut member;
A second structural member rotatable relative to the first structural member;
A plurality of flexible valve members for connecting the first structural member to the second structural member, the rotation of the second structural member relative to the first structural member in an open state by the connection; A plurality of flexible valve members biasing the valve member between closed states;
19. A stent according to item 18, comprising:
(Item 20)
Item 20. The stent of item 19, wherein rotation of the second structural member is responsive to a natural flow of bodily fluid.
(Item 21)
19. A stent according to item 18, wherein the prosthetic valve includes a plurality of flexible leaflets having seams at the intersection of two strut members.
(Item 22)
Item 22. The stent of item 21, wherein the prosthetic valve includes a skirt material coupled to the strut member.
(Item 23)
Item 12. The stent of item 11, wherein the strut member is configured to form one of a cylindrical shape, a conical shape, or an hourglass shape.
(Item 24)
A prosthetic valve assembly implantable in a body lumen,
A support structure comprising a plurality of elongate strut members interconnected by a plurality of swivel joints, wherein the swivel joint cooperates with the stent member to definitively define a forming structure between a compression orientation and an expansion orientation. A supporting structure;
A prosthetic valve connected to the support structure;
A prosthetic valve assembly comprising:
(Item 25)
25. The assembly of item 24, further comprising an actuation mechanism that biases the swivel joint within a range of motion.
(Item 26)
25. The assembly of item 24, wherein the swivel joint forms a scissor mechanism with the first strut member and the second strut member.
(Item 27)
27. An assembly according to item 26, wherein the strut member is configured as a series of connected scissor mechanisms.
(Item 28)
The artificial valve is
A first structural member coupled to the strut member;
A second structural member rotatable relative to the first structural member;
A plurality of flexible valve members for connecting the first structural member to the second structural member, the rotation of the second structural member relative to the first structural member in an open state by the connection; A plurality of flexible valve members biasing the valve member between closed states;
25. The assembly of item 24, comprising:
(Item 29)
30. The assembly of item 28, wherein the rotation of the second structural member is responsive to a natural flow of bodily fluid.
(Item 30)
25. An assembly according to item 24, wherein the prosthetic valve includes a plurality of flexible leaflets having a seam at the intersection of two strut members.
(Item 31)
32. The assembly of item 30, wherein the prosthetic valve includes a skirt material coupled to the strut member.
(Item 32)
25. The assembly of item 24, wherein the forming structure is one of a cylindrical shape, a conical shape, or an hourglass shape.
(Item 33)
A prosthetic valve assembly implantable in a body lumen,
A medical stent,
A plurality of elongated strut members including a first strut member and a second strut;
A swivel joint connecting the first strut member and the second strut member;
A medical stent comprising:
An artificial valve connected to the support structure and
A prosthetic valve assembly comprising:
(Item 34)
34. The assembly of item 33, wherein the swivel joint forms a scissor mechanism with the first strut member and the second strut member.
(Item 35)
35. The assembly of item 34, wherein the swivel joint bisects the first strut member and the second strut member.
(Item 36)
35. The assembly of item 34, wherein the plurality of strut members are configured as a series of connected scissor mechanisms.
(Item 37)
34. The assembly of item 33, wherein the swivel joint interconnects a first end of the first strut member to a first end of the second strut member.
(Item 38)
34. The assembly of item 33, further comprising an adjustment mechanism that applies a force to bias the strut member about the swivel joint within a range of motion.
(Item 39)
34. The assembly of item 33, wherein the strut member is non-linear.
(Item 40)
The artificial valve is
A first structural member coupled to the strut member;
A second structural member rotatable relative to the first structural member;
A plurality of flexible valve members for connecting the first structural member to the second structural member, the rotation of the second structural member relative to the first structural member in an open state by the connection; A plurality of flexible valve members biasing the valve member between closed states;
34. The assembly of item 33, comprising:
(Item 41)
41. The assembly of item 40, wherein rotation of the second structural member is responsive to a natural flow of bodily fluid.
(Item 42)
34. The assembly of item 33, wherein the prosthetic valve includes a plurality of flexible leaflets having seams at the intersection of two strut members.
(Item 43)
45. The assembly of item 42, wherein the prosthetic valve includes a skirt material coupled to the strut member.
(Item 44)
34. The assembly of item 33, wherein the strut member is one of a cylindrical shape, a conical shape, or an hourglass shape.
(Item 45)
A method of making a support device that is implantable within a body lumen, comprising:
Interconnecting a plurality of elongate strut members with a plurality of swivel joints so that the swivel joint can cooperate with the stent member to adjust the forming structure between a compression orientation and an expanded orientation; Defining a method.
(Item 46)
46. The method of item 45, further comprising coupling an actuation mechanism that biases the swivel joint within a range of motion.
(Item 47)
46. The method of item 45, further comprising coupling a prosthetic valve to the molded structure.
(Item 48)
The artificial valve is
A first structural member coupled to the strut member;
A second structural member rotatable relative to the first structural member;
A plurality of flexible valve members connecting the first structural member to the second structural member, wherein the connection causes rotation of the second structural member relative to the first structural member to an open state; A plurality of flexible valve members biasing the valve member between closed states;
48. The method of item 47 comprising.
(Item 49)
A method for producing a medical stent that can be implanted in a body lumen, comprising:
Making a plurality of elongated strut members including a first strut member and a second strut member;
Connecting a swivel joint with the first strut member and the second strut member;
Including a method.
(Item 50)
50. The method of item 49, further comprising coupling an adjustment mechanism to the strut member that exerts a force biasing the strut member about the swivel joint within a range of motion.
(Item 51)
50. The method of item 49, further comprising coupling a prosthetic valve to the strut member.
(Item 52)
The artificial valve is
A first structural member coupled to the strut member;
A second structural member rotatable relative to the first structural member;
A plurality of flexible valve members for connecting the first structural member to the second structural member, the rotation of the second structural member relative to the first structural member in an open state by the connection; A plurality of flexible valve members biasing the valve member between closed states;
52. The method of item 51 comprising.
(Item 53)
A method of fabricating a prosthetic valve assembly that is implantable within a biological lumen, comprising:
Creating a support structure comprising a plurality of elongated strut members interconnected by a plurality of swivel joints, wherein the swivel joint cooperates with a stent member to form a molded structure between a compression orientation and an expanded orientation; Definably adjustable, and
Coupling an artificial valve to a support structure;
Including a method.
(Item 54)
54. The method of item 53, further comprising including an actuation mechanism that biases the swivel joint within a range of motion.
(Item 55)
The artificial valve is
A first structural member coupled to the strut member;
A second structural member rotatable relative to the first structural member;
A plurality of flexible valve members for connecting the first structural member to the second structural member, the rotation of the second structural member relative to the first structural member in an open state by the connection; A plurality of flexible valve members biasing the valve member between closed states;
54. The method of item 53, comprising.
(Item 56)
A method of making a prosthetic valve assembly implantable in a biological lumen, comprising:
Producing a medical stent, the medical stent comprising:
A plurality of elongated strut members including a first strut member and a second strut member;
A swivel joint connected to the first strut member and the second strut member;
Comprising, and
Connecting the artificial valve to the support structure;
Including a method.
(Item 57)
57. The method of item 56, further comprising fabricating an adjustment mechanism that exerts a force biasing the strut member about the swivel joint within a range of motion.
(Item 58)
The artificial valve is
A first structural member coupled to the strut member;
A second structural member rotatable relative to the first structural member;
A plurality of flexible valve members for connecting the first structural member to the second structural member, the rotation of the second structural member relative to the first structural member in an open state by the connection; A plurality of flexible valve members biasing the valve member between closed states;
58. The method of item 56, comprising:

Claims (58)

A support device implantable in a body lumen,
A plurality of elongate strut members interconnected by a plurality of swivel joints, the swivel joints cooperating with the stent members to definitively define the forming structure between a compression orientation and an expansion orientation. A support device comprising:   The apparatus of claim 1, further comprising an actuating mechanism that biases the swivel joint within a range of motion.   The apparatus of claim 1, wherein the swivel joint forms a scissor mechanism with the first strut member and the second strut member.   The apparatus of claim 3, wherein the strut member is configured as a series of connected scissor mechanisms.   The apparatus of claim 1, further comprising a prosthetic valve coupled to the molded structure. The artificial valve is
A first structural member coupled to the strut member;
A second structural member rotatable relative to the first structural member;
A plurality of flexible valve members for connecting the first structural member to the second structural member, the rotation of the second structural member relative to the first structural member in an open state by the connection; A plurality of flexible valve members biasing the valve member between closed states.   The apparatus of claim 6, wherein rotation of the second structural member is responsive to a natural flow of bodily fluid.   6. The apparatus of claim 5, wherein the prosthetic valve includes a plurality of flexible leaflets having seams at the intersection of two strut members.   The apparatus of claim 8, wherein the prosthetic valve includes a skirt material coupled to the strut member.   The apparatus of claim 1, wherein the forming structure is one of a cylindrical shape, a conical shape, or an hourglass shape. A medical stent implantable in a body lumen,
A plurality of elongated strut members including a first strut member and a second strut;
And a swivel joint connecting the first strut member and the second strut member.   The stent according to claim 11, wherein the swivel joint forms a scissor mechanism by the first strut member and the second strut member.   The stent according to claim 12, wherein the swivel joint bisects the first strut member and the second strut member.   The stent of claim 12, wherein the plurality of strut members are configured as a series of connected scissor mechanisms.   The stent of claim 11, wherein the swivel joint interconnects a first end of the first strut member with a first end of the second strut member.   The stent according to claim 11, further comprising an adjustment mechanism that applies a force biasing the strut member about the swivel joint within a range of motion.   The stent according to claim 11, wherein the strut member is non-linear.   The stent of claim 11, further comprising a prosthetic valve coupled to the strut member. The artificial valve is
A first structural member coupled to the strut member;
A second structural member rotatable relative to the first structural member;
A plurality of flexible valve members for connecting the first structural member to the second structural member, the rotation of the second structural member relative to the first structural member in an open state by the connection; 19. A stent according to claim 18, comprising a plurality of flexible valve members biasing the valve member between closed states.   20. The stent of claim 19, wherein the rotation of the second structural member is responsive to a natural flow of body fluid.   The stent according to claim 18, wherein the prosthetic valve includes a plurality of flexible leaflets having seams at the intersection of two strut members.   The stent according to claim 21, wherein the prosthetic valve includes a skirt material coupled to the strut member.   The stent of claim 11, wherein the strut member is configured to form one of a cylindrical shape, a conical shape, or an hourglass shape. A prosthetic valve assembly implantable in a body lumen,
A support structure comprising a plurality of elongate strut members interconnected by a plurality of swivel joints, wherein the swivel joint cooperates with the stent member to definitively define a forming structure between a compression orientation and an expansion orientation. A supporting structure;
A prosthetic valve assembly connected to the support structure.   25. The assembly of claim 24, further comprising an actuation mechanism that biases the swivel joint within a range of motion.   25. The assembly of claim 24, wherein the swivel joint forms a scissor mechanism with the first strut member and the second strut member.   27. The assembly of claim 26, wherein the strut member is configured as a series of connected scissor mechanisms. The artificial valve is
A first structural member coupled to the strut member;
A second structural member rotatable relative to the first structural member;
A plurality of flexible valve members for connecting the first structural member to the second structural member, the rotation of the second structural member relative to the first structural member in an open state by the connection; 25. The assembly of claim 24, comprising a plurality of flexible valve members that bias the valve member between closed states.   30. The assembly of claim 28, wherein rotation of the second structural member is responsive to a natural flow of bodily fluid.   25. The assembly of claim 24, wherein the prosthetic valve includes a plurality of flexible leaflets having seams at the intersection of two strut members.   32. The assembly of claim 30, wherein the prosthetic valve includes a skirt material coupled to the strut member.   25. The assembly of claim 24, wherein the forming structure is one of a cylindrical shape, a conical shape, or an hourglass shape. A prosthetic valve assembly implantable in a body lumen,
A medical stent,
A plurality of elongated strut members including a first strut member and a second strut;
A medical stent, comprising: a swivel joint connecting the first strut member and the second strut member;
A prosthetic valve assembly comprising: a prosthetic valve connected to a support structure.   34. The assembly of claim 33, wherein the swivel joint forms a scissor mechanism with the first strut member and the second strut member.   35. The assembly of claim 34, wherein the swivel joint bisects the first strut member and the second strut member.   35. The assembly of claim 34, wherein the plurality of strut members are configured as a series of connected scissor mechanisms.   34. The assembly of claim 33, wherein the swivel joint interconnects a first end of the first strut member to a first end of the second strut member.   34. The assembly of claim 33, further comprising an adjustment mechanism that applies a force biasing the strut member about the swivel joint within a range of motion.   34. The assembly of claim 33, wherein the strut member is non-linear. The artificial valve is
A first structural member coupled to the strut member;
A second structural member rotatable relative to the first structural member;
A plurality of flexible valve members for connecting the first structural member to the second structural member, the rotation of the second structural member relative to the first structural member in an open state by the connection; 34. The assembly of claim 33, comprising a plurality of flexible valve members that bias the valve member between closed states.   41. The assembly of claim 40, wherein rotation of the second structural member is responsive to a natural flow of bodily fluid.   34. The assembly of claim 33, wherein the prosthetic valve includes a plurality of flexible leaflets having seams at the intersection of two strut members.   43. The assembly of claim 42, wherein the prosthetic valve includes a skirt material coupled to the strut member.   34. The assembly of claim 33, wherein the strut member is one of a cylindrical shape, a conical shape, or an hourglass shape. A method of making a support device that is implantable within a body lumen, comprising:
Interconnecting a plurality of elongate strut members with a plurality of swivel joints so that the swivel joint can cooperate with the stent member to adjust the forming structure between a compression orientation and an expanded orientation; Defining a method.   46. The method of claim 45, further comprising coupling an actuation mechanism that biases the swivel joint within a range of motion.   46. The method of claim 45, further comprising coupling a prosthetic valve to the molded structure. The artificial valve is
A first structural member coupled to the strut member;
A second structural member rotatable relative to the first structural member;
A plurality of flexible valve members connecting the first structural member to the second structural member, wherein the connection causes rotation of the second structural member relative to the first structural member to an open state; 48. A method according to claim 47, comprising a plurality of flexible valve members biasing the valve member between closed states. A method for producing a medical stent that can be implanted in a body lumen, comprising:
Making a plurality of elongated strut members including a first strut member and a second strut member;
Connecting a swivel joint to the first strut member and the second strut member.   50. The method of claim 49, further comprising coupling an adjustment mechanism to the strut member that exerts a force biasing the strut member about the swivel joint within a range of motion.   50. The method of claim 49, further comprising coupling a prosthetic valve to the strut member. The artificial valve is
A first structural member coupled to the strut member;
A second structural member rotatable relative to the first structural member;
A plurality of flexible valve members for connecting the first structural member to the second structural member, the rotation of the second structural member relative to the first structural member in an open state by the connection; 52. A method according to claim 51, comprising: a plurality of flexible valve members biasing the valve member between closed states. A method of fabricating a prosthetic valve assembly that is implantable within a biological lumen, comprising:
Creating a support structure comprising a plurality of elongated strut members interconnected by a plurality of swivel joints, wherein the swivel joint cooperates with a stent member to form a molded structure between a compression orientation and an expanded orientation; Definably adjustable, and
Coupling the prosthetic valve to the support structure.   54. The method of claim 53, further comprising including an actuation mechanism that biases the swivel joint within a range of motion. The artificial valve is
A first structural member coupled to the strut member;
A second structural member rotatable relative to the first structural member;
A plurality of flexible valve members for connecting the first structural member to the second structural member, the rotation of the second structural member relative to the first structural member in an open state by the connection; 54. A method according to claim 53, comprising: a plurality of flexible valve members biasing the valve member between closed states. A method of making a prosthetic valve assembly implantable in a biological lumen, comprising:
Producing a medical stent, the medical stent comprising:
A plurality of elongated strut members including a first strut member and a second strut member;
A swivel joint connected to the first strut member and the second strut member;
Connecting the prosthetic valve to the support structure.   57. The method of claim 56, further comprising fabricating an adjustment mechanism that exerts a force biasing the strut member about the swivel joint within a range of motion. The artificial valve is
A first structural member coupled to the strut member;
A second structural member rotatable relative to the first structural member;
A plurality of flexible valve members for connecting the first structural member to the second structural member, the rotation of the second structural member relative to the first structural member in an open state by the connection; 57. A method according to claim 56, comprising a plurality of flexible valve members biasing the valve member between closed states.

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